Determine HIV-1/2 Ag/Ab is the first approved test to be
able to detect both the HIV-1 antigen and HIV-1, HIV-2
antibodies in a single test.

Alere shares were up 5.5 percent in extended trading after
closing at $31.29 on the New York Stock Exchange on Thursday.

The FDA said in a statement that the detection of HIV-1
antigen allows earlier detection of the infection than by
testing it for antibodies, which are produced in response to
harmful antigens. ()

"This test helps diagnose HIV infection at an earlier time
in outreach settings, allowing individuals to seek medical care
sooner," said Karen Midthun, director of the FDA's Center for
Biologics Evaluation and Research.

There are two types of infections, HIV-1 and HIV-2, the most
common one being the HIV-1, and most cases of HIV-2 are found in
Africa and has also been reported in North America and Europe,
the FDA said.

According to the Centers for Disease Control and Prevention,
about 50,000 people are infected with HIV in the United States
each year.

Waltham, Massachusetts-based Alere makes a range of
diagnosis tools such as home pregnancy tests and fertility and
monitoring kits.